Glossary Term
Alpha Prototype
Definition
An Alpha Prototype is an early version of a medical device or product developed to validate initial design concepts and functionalities. It is typically constructed using basic materials and methods, allowing engineers to test form, fit, and functionality in a controlled environment before advancing to more refined iterations.
Relevance to the MedTech Industry
Alpha Prototypes play a critical role in the iterative design process, enabling MedTech companies to evaluate and refine initial concepts. They provide a tangible representation of the device, allowing teams to identify design flaws, test core functionalities, and gather initial stakeholder feedback, ensuring the product meets user and regulatory requirements.
Additional Information & Related Terms
Beta Prototype A more advanced prototype refined based on Alpha Prototype feedback.
Design Validation Ensures the device meets user needs and intended use, following refinement from prototypes.
Iterative Prototyping A process that incorporates Alpha Prototypes to refine design and functionality.
Preclinical Testing Involves simulated testing to evaluate initial design feasibility and functionality.